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12
Ago
FDA’s program to speed up US manufacturing buildouts
While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official...[PharmaManufacturing]
24
Ott
ECHA & REACh - SMEs to apply for company size validation before making REACH submissions
The European Commission has adopted the revised REACH Fee Regulation. Micro, small, and medium-sized...
Changes to e-submission requirements for CEP applications for 1 November 2025
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the requirements...
US FDA Publishes Filing Checklists to Prevent Submission Delays
The US Food and Drug Administration (FDA) published the internal checklists its staff reference when...
22
Approvato dal Parlamento europeo il pacchetto “One substance, one assessment” - Regole UE più semplici e trasparenti per la chimica
Nell'ottica di semplificare l'assetto normativo e burocratico che impatta sulle imprese...
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30 Lug
EMA - Nitrosamine impurities
25 Lug
EU CRITICAL MEDICINE ACTS & Normative Ambientali
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